Trial Outcomes & Findings for Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma (NCT NCT00268983)

Last Updated: 2017-01-09

Results Overview

Event-free survival is defined as the time from the date of randomization to the first occurrence of (whichever came first) progressive disease, death, or additional Non-Hodgkins Lymphoma (NHL) therapy due to disease-related symptoms, threatened end-organ function, cytopenias secondary to NHL, massive bulk disease, or steady progression over at least 6 months. Progressive disease is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm\^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)

Results posted on

2017-01-09

Participant Flow

The study intended to recruit 506 participants to be randomized (1:1) to one of two treatment arms. However, due to feasibility issues, the study was stopped after only 15 participants were enrolled. Of these, 1 participant withdrew prior to receiving the first dose of study treatment; therefore, only 14 comprised the study population.

Participant milestones

Participant milestones
Measure	Rituximab 375 mg/m^2 Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Overall Study STARTED	6	8
Overall Study COMPLETED	3	8
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab 375 mg/m^2 Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Overall Study Death	3	0

Baseline Characteristics

Comparison Of Rituximab Versus Tositumomab and Iodine I 131 Tositumomab (BEXXAR® Therapeutic Regimen) For Patients With Relapsed Follicular Non-Hodgkins Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes	Total n=14 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 14.4 • n=5 Participants	53.1 years STANDARD_DEVIATION 8.0 • n=7 Participants	53.3 years STANDARD_DEVIATION 11.0 • n=5 Participants
Gender Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: From the date of randomization to the first occurrence of progressive disease, death, or additional Non-Hodgkins Lymphoma (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)

Population: Intent-to-Treat (ITT)-Exposed Population: all participants who received at least one dose of treatment

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Event-free Survival (EFS)	9 Months Interval 6.3 to 12.8	NA Months Four of the 8 subjects in the TST/I-131 TST arm had not experienced an event by the time of their last follow-up, so there were insufficient events in the TST/I-131 TST arm to estimate the EFS, PFS or DOR

PRIMARY outcome

Timeframe: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)

Population: ITT-Exposed Population

Progression-free survival is defined as the time from the initial date of dosing to the first documented disease progression or death. Disease assessment was based on the International Workshop to Standardize Response Criteria (IWSRC) for Non-Hodgkin's Lymphoma (NHL). Progression is defined as at least a 50% increase in the sum of the perpendicular diameters of all measurable lesions and the appearance of new lesions at least 1.4 centimeters (cm) x 1.4 cm (i.e., 2.0 cm\^2) by radiographic evaluation or greater than 1.0 cm by palpation upon physical examination.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Progression-free Survival	9 months Interval 6.3 to 12.8	NA months Four of the 8 subjects in the TST/I-131 TST arm had not experienced an event by the time of their last follow-up, so there were insufficient events in the TST/I-131 TST arm to estimate the EFS, PFS or DOR

SECONDARY outcome

Timeframe: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually

Population: ITT-Exposed Population

Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms (by the IWSRC) if present before therapy, and normalization of those biochemical abnormalities definitely assignable to NHL. Confirmation of response was carried out by an independent reviewer

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants Achieving Response Complete response	1 Participants	6 Participants
Number of Participants Achieving Response Confirmed complete response	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Participants were followed for response at Week 7, Week 13, every 3 months for the first and second year, every 6 months for the third year, and then annually

Population: ITT-Exposed Population. Only those participants with confirmed or unconfirmed complete response or partial response were analyzed for duration of response.

Response duration is defined as the time from the first documented response (complete response, complete response unconfirmed, or partial response) until disease progression. Partial response is defined as at least a 50% decrease in the product of two perpendicular diameters of all measurable lesions; no increase in the size of other nodes, liver, or spleen; and no new disease sites.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=4 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Duration of Response	7.3 months Interval 6.0 to The upper limit of the 95% confidence interval for the median was not estimable due to a small sample size and a small number of events.	NA months Four of the 8 subjects in the TST/I-131 TST arm had not experienced an event by the time of their last follow-up, so there were insufficient events in the TST/I-131 TST arm to estimate the EFS, PFS or DOR

SECONDARY outcome

Timeframe: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)

Population: ITT-Exposed Population

Time to death is defined as the time from treatment start to the date of death. As a median time to death is not presented for either group, see the outcome measure entitled "Number of Participants Who Had Died by the Month Indicated" for data regarding time to death.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Time to Death	NA months Only 3 of the 6 subjects in the rituximab arm had died by the time of their last follow-up, so there were insufficient events to estimate median OS.	NA months None of the 8 subjects in the TST/I-131 TST arm died by the time of their last follow-up, so there were insufficient events in the TST/I-131 TST arm to estimate median OS.

SECONDARY outcome

Timeframe: From first dose of treatment until disease progression or death, whichever came first (median follow-up for the Rituximab and TST/I-131 TST groups was 62 and 91.5 months, respectively)

Population: ITT-Exposed Population

The median time to death could not be calculated for participants in either treatment group; thus, data are shown as the number of participants who had died by the month indicated.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=3 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants Who Had Died by the Month Indicated 6.3 Months	1 participants	0 participants
Number of Participants Who Had Died by the Month Indicated 33.1 Months	1 participants	0 participants
Number of Participants Who Had Died by the Month Indicated 39.6 Months	1 participants	0 participants

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population

Time to next treatment is defined as time from the date of randomization until the new treatment is needed for NHL. Because too few evaluable participants were enrolled/treated, analysis of the time to next treatment was not conducted as planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population excluding participants that did not have data within the 120 days of study drug administration.

Hematologic toxicity includes the analysis of hematologic nadir, which is defined as the lowest hematology value within 120 days of study drug administration.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=3 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Hematologic Nadir for Absolute Neutrophil Count	—	2.6 10^3/cubic millimeter (mm^3) Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Hematologic Nadir for Hemoglobin	12.3 Grams per deciliter (G/dL) Interval 10.0 to 15.0	11.6 Grams per deciliter (G/dL) Interval 9.0 to 14.0

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count Platelets	161.5 10^3/microliter (µL) Interval 138.0 to 324.0	57.0 10^3/microliter (µL) Interval 18.0 to 84.0
Hematologic Nadir for Platelet Count and White Blood Cell (WBC) Count WBC Count	4.8 10^3/microliter (µL) Interval 3.0 to 7.0	1.8 10^3/microliter (µL) Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to nadir is defined as the number of days from the last administration of study drug to nadir.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Time to Nadir Values for the Indicated Hematological Parameters Absolute Neutrophil Count (n=0,3)	NA Days Standard Deviation NA There was no participants available to determine absolute neutrophil count.	17.0 Days Standard Deviation 17.32
Time to Nadir Values for the Indicated Hematological Parameters Hemoglobin (n=6,8)	44.3 Days Standard Deviation 25.57	38.5 Days Standard Deviation 16.19
Time to Nadir Values for the Indicated Hematological Parameters Platelet Count (n=6,8)	33.3 Days Standard Deviation 18.00	32.6 Days Standard Deviation 4.21
Time to Nadir Values for the Indicated Hematological Parameters WBC Count (n=6,8)	45.8 Days Standard Deviation 23.83	41.5 Days Standard Deviation 4.93

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population

Hematologic nadir is defined as the lowest hematology value within 120 days of study drug administration. Time to recovery to Baseline grade is defined as the number of days from the last administration of study drug to a post-nadir hematology value of unmaintained Baseline grade or lower.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters Absolute Neutrophil Count (n=0,1)	NA Days There was no participants who had a drop in neutrophil count, therefore the Median and a 95% CI were unable to be calculated.	7 Days There was only 1 participant with a baseline value ; therefore, time to recovery to baseline grade could only be evaluated for that one subject.
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters Hemoglobin (n=6,8)	46.5 Days Interval 26.0 to 57.0	52.0 Days Interval 29.0 to 77.0
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters Platelets Count (n=6,8)	31.0 Days Interval 22.0 to 57.0	49.5 Days Interval 43.0 to 56.0
Time to Recovery to Baseline Grade for the Indicated Hematological Parameters WBC Count (n=6,8)	52.0 Days Interval 28.0 to 64.0	73.0 Days Interval 57.0 to 77.0

SECONDARY outcome

Timeframe: Time from study randomization to 120 days after study drug administration

Population: ITT-Exposed Population. Participants with a Grade 3/4 toxicity level for the indicated hematological parameters were analyzed (reflected by n=X, X). Different participants may have been analyzed for different parameters; thus, the overall number analyzed reflects everyone in the ITT-Exposed Population.

Duration of Grade 3/4 toxicity is defined as the time between the date of the first Grade 3/4 lab result to the first lab date with a Grade of 0, 1, or 2 result. Laboratory abnormalities will be recorded as AEs using NCI CTCAE, Version 3, if they are associated with clinical squeal and/or require an intervention. Specific AEs not listed in the NCI criteria will be graded as follows: 1. Mild: An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities, 2. Moderate: An event that is sufficiently discomforting to interfere with normal everyday activities, 3. Severe: An event that prevents normal everyday activities, 4. Life-threatening or debilitating, and 5. Death

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters Absolute Neutrophil Count (n=0,1)	NA Days No participants reached Grade 3/4 toxicity so there was no duration to calculate.	910 Days Interval 910.0 to 910.0
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters Hemoglobin (n=0,0)	NA Days No participants reached Grade 3/4 toxicity so there was no duration to calculate.	NA Days No participants reached Grade 3/4 toxicity so there was no duration to calculate.
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters Platelet Count (n=0,3)	NA Days No participants reached Grade 3/4 toxicity so there was no duration to calculate.	22 Days Interval 8.0 to 22.0
Duration of Grade 3/4 Toxicity for the Indicated Hematological Parameters WBC Count (n=0,4)	NA Days No participants reached Grade 3/4 toxicity so there was no duration to calculate.	22 Days Interval 4.0 to 35.0

SECONDARY outcome

Population: ITT-Exposed Population

Hypothyroidism is defined as elevated Thyroid-Stimulating Hormone (TSH) or current history of using thyroid medication. The frequency of hypothyroidism at study enrollment will be determined, and participants with hypothyroidism at Baseline were excluded from analysis.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants That Developed Hypothyroidism	0 Participants	2 Participants

SECONDARY outcome

Timeframe: First 24 hours of study drug administration.

Population: ITT-Exposed Population

An infusion reaction is defined as any adverse event that occured within 24 hours of an infusion. An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants With an Infusion Reaction	0 participants	1 participants

SECONDARY outcome

Timeframe: Time of treatment until 90 days post-treatment

Population: ITT-Exposed Population

The frequency of hospitalizations within 90 days of treatment was summarized. Because too few evaluable participants were enrolled/treated, analysis of the number of hospitalizations was not conducted as planned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: ITT-Exposed Population

The cumulative incidence of myelodysplasia/leukemia was estimated.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants With Myelodysplasia/Leukemia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From randomization through Week 26

Population: ITT-Exposed Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant temporally associated with the use of a medicinal product, whether or not it is considered related to the medicinal product. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a Grade 4 (life threatening or disabling) non-hematologic laboratory abnormality assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Outcome measures
Measure	Rituximab 375 mg/m^2 n=6 Participants Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 Participants Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE) Non Serious Adverse Evnts	6 Participants	8 Participants
Number of Participants With Any Serious Adverse Event (SAE) and Non-serious Adverse Event (AE) Serious Adverse events	4 Participants	4 Participants

Adverse Events

Rituximab 375 mg/m^2

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

TST/I-131 TST

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab 375 mg/m^2 n=6 participants at risk Rituximab 375 milligrams per meters squared (mg/m\^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)	TST/I-131 TST n=8 participants at risk Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes; Therapeutic dose, Given only once between Day 7 and Day 14: 450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-cell lymphoma unspecified	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Gastrointestinal disorders Nausea	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Gastrointestinal disorders Vomiting	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
General disorders Pyrexia	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Immune system disorders Hypersensitivity	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Infections and infestations Lower respiratory tract infection	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sebaceous carcinoma	0.00% 0/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	12.5% 1/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Respiratory, thoracic and mediastinal disorders Respiratory failure	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .
Vascular disorders Hemorrhage	16.7% 1/6 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .	0.00% 0/8 • Serious adverse events (SAEs) and non-serious AEs were collected from randomization until Week 26 after participants' first dose. Beyond Week 26, events assessed as possibly related to study participation or drug administration were reported .

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER